Prothena Corporation plc, a late-stage clinical biotechnology company, focuses on the discovery, development, and commercialization of protein immunotherapy programs for the treatment of diseases that involve amyloid or cell adhesion in Ireland Research and Development Pipeline The company’s research and development pipeline includes three therapeutic antibody programs that it intends to advance: NEOD001; PRX002; and PRX003. NEOD001 The company’s most advanced product development program, NEOD001, targets AL amyloidosis. Systemic amyloidoses, including AL, AA and ATTR amyloidosis, are a group of diseases caused by tissue deposition of amyloid proteins that result in progressive organ damage. The most common type, AL amyloidosis or primary systemic amyloidosis, results from hematological disorder involving abnormal plasma cells. Plasma cells normally produce light chains that pair with heavy chains to make functional antibodies. NEOD001 is a humanized monoclonal antibody that specifically targets the circulating misfolded soluble light chain and deposited insoluble amyloid that accumulates in AL amyloidosis. In 2014, the company initiated The VITAL Amyloidosis Study, a Phase 3 clinical trial for NEOD001 in patients with AL amyloidosis. The company is conducting The VITAL Amyloidosis Study, a Phase 3 global registrational trial, and a concurrent Phase 1/2 trial for its lead antibody, NEOD001, for the potential treatment of patients with AL amyloidosis. NEOD001 received Fast Track designation from the U.S. Food and Drug Administration (the FDA) in 2014. PRX002 In 2013, the company entered into a license, development, and commercialization agreement with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. (collectively, Roche) to develop and commercialize certain antibodies that target alpha-synuclein, including PRX002. Together, the company and Roche aim to develop PRX002 as a disease-modifying treatment for Parkinson’s disease and potentially other synucleinopathies. During 2014, the company and Roche advanced PRX002 into clinical development with the initiation of two Phase 1 studies. PRX003 The company is developing PRX003, a monoclonal antibody targeting melanoma cell adhesion molecule (MCAM) for the potential treatment of psoriasis and other inflammatory diseases. The company’s research in the area of cell adhesion has uncovered unique insights into MCAM function, allowing it to develop specific and novel antibodies that block MCAM’s VELCROTM-like function and may serve as therapeutics to prevent disease causing cells from spreading into tissue. Discovery Programs The company’s pipeline also includes various late discovery-stage programs for which it is testing the efficacy of antibodies in preclinical models of diseases related to amyloid or cell adhesion. Research and Development The company’s research and development expenses totaled $38.5 million in 2014. Strategy The key elements of the company’s strategy are to continue to discover antibodies directed against novel targets related to amyloid or cell adhesion; quickly translate its research discoveries into clinical development; establish early clinical proof of concept with its therapeutic antibodies; focus on diseases that lack effective therapies; strategically collaborate or out-license select programs; highly leverage external talent and resources; collaborate with scientific and clinical experts in disease areas of interest; and evaluate commercialization strategies in order to maximize the value of its product candidates or future potential products. Intellectual Property The company owns or holds exclusive licenses to various issued U.S. patents and pending U.S. patent applications, as well as issued foreign patents and pending Patent Corporation Treaty applications and foreign counterparts. As of February 27, 2015, the company’s patent portfolio included the following patents or patent applications that it owns or has exclusively licensed from other parties:approximately 57 patent and patent applications related to AL or AA amyloidosis, including its NEOD001 program; approximately 133 patents and patent applications related to Parkinson’s disease and other synucleinopathies, including its PRX002 program; approximately 20 patents and patent applications related to psoriasis and other inflammatory diseases, including its PRX003 program; and approximately 77 patents and patent applications related to other potential targets of intervention. Under a License Agreement with the University of Tennessee Research Foundation, the company has exclusively licensed from the University of Tennessee its joint ownership interest in certain patents jointly owned with the company. Under a License Agreement with The Regents of the University of California, the company has exclusively licensed from the University of California its joint ownership interest in certain patents jointly owned with it. Under an Amended and Restated Intellectual Property License and Contribution Agreement with Elan Corporation, plc (Elan) and certain of its affiliates, the company has exclusively licensed from Elan and those affiliates certain patents and patent applications owned by them, and exclusively sublicensed from Elan and those affiliates certain patents and patent applications owned by Janssen Alzheimer Immunotherapy.
prothena corp plc (PRTA:NASDAQ GS)
Phone: 353 1 902 3519
Fax: 353 1 902 3510www.prothena.com
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